History Of Generic Drugs:

The origin of Generic Drugs can be found from 1920s, Bayer a Pharmaceutical Company that produces Aspirin fought vigorously to keep generic versions off the shelves. Bayer lost in court, and consumers suddenly had an array of choices in generic aspirin. Today, generic drugs are both widely available and carefully regulated. This wasn't always the case. Before some decades back, drug companies could release new products with far less testing than is required today. The real test of a drug's safety and effectiveness came after its entry into the market. If too many patients had bad reactions, the drug could be pulled off the shelves. The danger of this approach became tragically clear when the sedative Thalidomide caused thousands of devastating birth defects in Europe, Canada, Latin America, Africa, and Asia.

New regulations

Those days effectively ended in 1962 when the Food and Drug Administration dramatically revamped the Federal Food, Drug, and Cosmetic Act, originally passed in 1938. It strengthened the drug testing laws already on the books, and for the first time, companies were required to prove that a drug was both safe and effective before it reached the market place. All new drugs had to go through a lengthy and expensive process that included large-scale human trials.

The new regulations applied to both brand name and generic drugs, a fact that slowed the release of new generics to a trickle. New generic drug’s had to go through the same investigational trials as any other drugs, even if its active ingredients were identical to an already established brand name drug. Companies also had to wait for the brand name patent to expire before they could even do the testing required to produce a generic. Most companies did not bother. By 1983, only 35 percent of the top-selling drugs with expired patents had a generic competitor, according to the Congressional Budget Office.

Stiff competition

Today, the rate of competition is closer to 100%. Generic versions crop up almost immediately after the patent on a brand name drug expires. The floodgates opened in 1984 with the passage of the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act. The FDA calls it "one of the most successful pieces of legislation ever passed."

The new law made it much easier and cheaper to bring a new generic drug to market. Instead of going through lengthy human trials, companies merely had to prove that their drug had the same active ingredients and that they performed in the body the same way as the brand-name drug. The act also increased the amount of time a company could hold an exclusive patent on a new drug. Within a year, the FDA received more than 1,000 applications for new generic drugs, and the Generic Drug industry was born.

The act dramatically changed the face of medicine. We've come a long way since the time when generic aspirin first hit the shelves.

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